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FAQs: About SOMAVERT

Frequently asked questions about SOMAVERT

Whether you are considering, starting, or currently taking SOMAVERT, you may have concerns and questions.
Here you will find answers to frequently asked questions about SOMAVERT.

About SOMAVERT

What is SOMAVERT?

SOMAVERT is a prescription medicine for acromegaly. It is approved for patients whose disease has not been controlled by surgery or radiation or for whom these options are not appropriate. The goal of treatment with SOMAVERT is to have a normal IGF-I level in the blood.

How does SOMAVERT work?

SOMAVERT blocks growth hormone (GH) activity in the liver to help reduce levels of IGF-I.

What can I expect from treatment with SOMAVERT?

The goal of treatment with SOMAVERT is to have a normal IGF-I level in the blood. In the pivotal study, a majority of patients treated with SOMAVERT achieved normal IGF-I levels.

  • In the study, SOMAVERT significantly lowered IGF-I levels at 12 weeks for all 3 doses (10 mg/day, 15 mg/day, and 20 mg/day). IGF-I levels were normalized for a majority of patients taking the 20 mg dose at week 12*
    • In this same study, the overall measured signs and symptoms of acromegaly (swelling, joint pain, headache, sweating, and weakness) improved in patients who took SOMAVERT compared with those who took a placebo
    • The majority of IGF-I reduction occurred within the first 2 weeks for patients taking SOMAVERT
  • In a post hoc analysis of the 12-week study, of the 57 patients who reached a normal IGF-I level and had at least one sign or symptom of acromegaly at that time, 91% reported improvement in these signs and symptoms at the time of normalization or thereafter
  • In a long-term, open-label extension to the original clinical trial, the majority of patients treated with SOMAVERT reached normal IGF-I levels for their age
    • In fact, at the end of 43 weeks, 93% of patients had a normal IGF-I level during at least 1 doctor visit during the study

*These data are from a clinical trial that involved 112 patients with acromegaly. Thirty-two patients received a placebo. Eighty were treated with SOMAVERT at 1 of 3 doses. Results for patients achieving normal IGF-I levels for their age were 10% of patients taking a placebo; 39% of those on 10 mg per day of SOMAVERT; 75% of those on 15 mg per day of SOMAVERT; and 82% of those on 20 mg per day of SOMAVERT.

These data come from the extension to the original clinical study of 109 patients (including 6 new patients).

How quickly will SOMAVERT work?

Many patients experienced decreased IGF-I levels in 2 weeks. In the 12-week pivotal study, 75% of the total mean reduction in IGF-I levels occurred within 2 weeks.*

*These data are from a clinical trial that involved 112 patients with acromegaly. Thirty-two patients received a placebo. Eighty were treated with SOMAVERT at 1 of 3 doses. Results for patients achieving normal IGF-I levels for their age were 10% of patients taking a placebo; 39% of those on 10 mg per day of SOMAVERT; 75% of those on 15 mg per day of SOMAVERT; and 82% of those on 20 mg per day of SOMAVERT.

How will I know if my IGF-I levels are normal?

At first, you will have to have blood tests every 4 to 6 weeks. This is to check your IGF-I levels. Your doctor may adjust your SOMAVERT dose based on these test results.

SOMAVERT safety and side effects

Who should not use SOMAVERT?

SOMAVERT should not be taken by anyone who is allergic to any of its ingredients. Please see full Patient Information.

What are the most common side effects of SOMAVERT?

The most common side effects with SOMAVERT are infection, pain, nausea, diarrhea, abnormal liver function tests, flu-like symptoms, and reaction at the injection site. These are not all of the possible side effects of SOMAVERT. For more information, speak to your doctor.

 

As someone taking SOMAVERT, what do I need to be aware of if I take medicine for diabetes?

Your doctor may need to lower your dose of insulin or other oral diabetes medicine because SOMAVERT has been shown to reduce serum glucose levels and insulin requirements.

Can I use SOMAVERT if I am pregnant?

SOMAVERT has not been studied in pregnant women. If you are pregnant, or plan to become pregnant, talk to your doctor about the risks and benefits of treatment with SOMAVERT.

Starting SOMAVERT

How should I use SOMAVERT?

SOMAVERT is given once a day by injection under the skin. Your healthcare provider will give you your first dose, and you or your caregiver will receive training on how to inject SOMAVERT.

How should I store SOMAVERT?

Store the package of SOMAVERT in a refrigerator. DO NOT FREEZE IT! After mixing the powder and liquid (do not shake), you may keep the mixed medicine at room temperature inside the vial or syringe, but you must inject the mixed SOMAVERT within 6 hours.

What if I mix my SOMAVERT dose but forget to inject it?

If it has been more than 6 hours since you mixed it, DO NOT use it. Call your doctor for advice. Please call the Pfizer Bridge Program®* at 1-800-645-1280 and tell them what happened and ask for a replacement.

*Certain programs and services powered by Pfizer RxPathways®.

What if a mixed SOMAVERT dose does not look clear?

DO NOT use it. The mixed dose should look clear once the powder is dissolved. If the dose looks cloudy, hazy, or colored, or if you see particles or foam, do not throw the vial away. Call your doctor for advice. Please call the Pfizer Bridge Program®* at 1-800-645-1280 and tell them what happened and ask for a replacement.

*Certain programs and services powered by Pfizer RxPathways®.

What if I forget to take my SOMAVERT dose?

If you forget to give yourself an injection of SOMAVERT, skip that dose. Get back on your schedule the next day. Do not inject a double dose to make up for a forgotten injection. If you have any questions about using SOMAVERT, ask your doctor.

How can I get SOMAVERT?

Your doctor fills out a Statement of Medical Necessity (SMN), which is like a prescription. Then your doctor sends it to the Pfizer Bridge Program®*.

*Certain programs and services powered by Pfizer RxPathways®.

What is the Pfizer Bridge Program?

Patients prescribed SOMAVERT can find help with navigating insurance coverage by calling the Pfizer Bridge Program at 1-800-645-1280. This program can help patients with:

  • Copay support for eligible commercially insured patients
  • Scheduling nurse training for self-injection

Learn more about the Pfizer Bridge Program now.

What if my insurance denies paying for my treatment?

If your insurance will not cover SOMAVERT, the Pfizer Bridge Program* will work with you and your doctor to determine any options to appeal. If the coverage is not available, the Pfizer Bridge Program can determine if you may be eligible for other options to help pay for your SOMAVERT.

*Certain programs and services powered by Pfizer RxPathways®.

What if I cannot afford my copay for SOMAVERT?

If you need help affording therapy, the Pfizer Bridge Program* can explore additional options including the SOMAVERT Copay/Coinsurance Program and any other resources that may be available.

Terms and Conditions apply. Please click here to learn more.

*Certain programs and services powered by Pfizer RxPathways®.